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NCT02210481 Clinical Trial

The Role of Intravitreal Glucose in Macular Thinning Following Surgery for Retinal Detachment or Epimacular Membrane

Vitrectomy Clinical Trial

— GLU-MAC  

Official title:
Impact of Intravitreal Glucose Rate in Macular Thinning Following Retinal Detachment or Epimacular Membrane Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02210481
Other study ID # AOL2010-02
Secondary ID
Status Completed
Phase N/A
First received August 5, 2014
Last updated November 9, 2017
Start date February 2014
Est. completion date December 2014

Study information
Verified date November 2017
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comparison between intravitreous glucose rate and macular thinning measured by Ocular Coherence Tomography (OCT) at 3 months post vitrectomy for retinal detachment or epimacular membrane. Hypothesis : Association between post-operative macular thickness and intravitreous glucose rate

Description:

Comparison between intravitreous glucose rate and macular thinning measured by OCT at 3 months post vitrectomy for retinal detachment or epimacular membrane. The cohort is divided in 2 groups, one with the thinnest macular measurement under 190µm, and the others above 190µm. We are looking for a correlation between increasing glucose rates and decreased macular thickness.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patient who underwent vitrectomy for retinal detachment or epimacular membrane

Exclusion Criteria:

- patient suffering of diabetes,

- recurrence of retinal detachment,

- age-related macular degeneration,

- post surgical macular oedema

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier Universitaire de Reims Reims

Sponsors (1)
Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary macular thickness measured by OCT 3 months post-operatively
Secondary visual acuity 3 months post-operatively
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